[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intracranial-meningioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intracranial-meningioma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,66,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100249231","phase-2-vismodegib-fak-inhibitor-gsk2256098-capivasertib-and-abemaciclib-in-treating-patients-with-progressive-meningiomas-100249231",false,"NCT02523014","Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas","Phase II Trial of SMO\u002F AKT\u002F NF2\u002FCDK Inhibitors in Progressive Meningiomas With SMO\u002F AKT\u002F NF2\u002FCDK Pathway Mutations","* Documentation of disease:\n\n  * Histologic documentation: histologically proven intracranial meningioma as documented by central pathology review\n  * Molecular documentation: Presence of SMO, PTCH1, NF2, CDKN2A, AKT1, PIK3CA, PTEN mutations, CDKN2A copy number loss, CDK4, CDK6, CCND1, CCND2, CCND3, or CCNE1 copy number gain in tumor sample as documented specifically by the central laboratory, regardless of whether prior genotype testing outside of the central laboratory was performed\n  * Progressive OR residual disease, as defined by the following:\n\n    * Residual measurable disease: residual measurable disease immediately after surgery without requirement for progression; for grade I disease, progression pre-operatively needs to be documented, with an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 25 months; for patients with SMO\u002FPTCH1 mutations enrolling to receive vismodegib, the change can occur between scans separated by up to 25 months; residual measurable disease will be defined by bidimensionally measurable lesions with clearly defined margins by MRI scans, with a minimum diameter of 10 mm in both dimensions\n    * Progressive measurable disease: progression defined as an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 25 months\n    * Post radiation patients: patients with measurable and progressive meningioma who have received radiation are potentially eligible, but need to show evidence of progressive disease after completion of radiation; if the progressive meningioma lesion has been radiated, at least 24 weeks must have elapsed from completion of radiation to registration; if the progressive lesion is outside of the radiation field, then an interval of at least 2 weeks must have elapsed from completion of radiation to registration\n* Measurable disease: measurable disease is defined by a bidimensionally measurable main lesion on MRI or computed tomography (CT) images (MRI preferred) with clearly defined margins and a minimum diameter of 10 mm in both dimensions; multifocal disease is allowed\n* Prior treatment\n\n  * Prior medical therapy is allowed but not required\n  * No limit on number of prior therapies\n  * No chemotherapy, or other investigational agents within 28 days prior to registration\n  * No other concurrent investigational agents or other meningioma-directed therapy (chemotherapy, radiation) while on study; additionally, no cases of nitrosourea or mitomycin C within 6 weeks prior to registration\n  * For patients treated with external beam radiation, interstitial brachytherapy or radiosurgery, an interval \\> 4 weeks must have elapsed from completion of radiation therapy to registration; if the progressive lesion is outside of the radiation field, then an interval of at least 2 weeks must have elapsed from completion of radiation to registration\n  * Steroid dosing stable for at least 4 days\n  * Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity from other agents with exception of alopecia and fatigue\n  * No craniotomy 28 days prior to and after registration\n* Not pregnant and not nursing:\n\n  \\* A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n* For patients with NF2\u002FCDKN2A\u002FAKT1\u002FPIK3CA\u002FPTEN mutation, CKDN2A copy number loss, or CDK4\u002FCDK6\u002FCCND1\u002FCCND2\u002FCCND3\u002FCCNE1 copy number gain: Age \\>= 18 years\n* For patients with SMO\u002FPTCH1 mutation: Age \\>= 30 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Patient history:\n\n  * Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for 6 months\n  * No metastatic meningiomas (as defined by extracranial meningiomas outside of CNS) allowed; spinal meningiomas are allowed\n  * No history of allergic reactions attributed to compounds of similar or biologic composition to assigned study drug\n  * No known active hepatitis B or C\n  * No current Child Pugh class B or C liver disease\n  * No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease within 28 days of registration)\n  * No uncontrolled hypertension defined as blood pressure (BP) \\> 140\u002F90\n  * No abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 28 days prior to registration\n  * No major surgery within 28 days prior to registration for any patients with AKT1\u002FPIK3CA\u002FPTEN mutations receiving capivasertib\n  * For patients going on to receive capivasertib (i.e. enrolled after Update #08)\n\n    * Patients should not have any of the following cardiac criteria:\n\n      * Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram (EKG) (e.g., complete left bundle branch block, third degree heart block)\n      * Any factors that increase the risk of corrected QT (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, potential for Torsade de Pointes, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval\n      * Experience any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) class \\>= II\n      * Uncontrolled hypertension (systolic blood pressure \\[SBP\\] \\\u003C 90 mmHg and\u002For diastolic blood pressure \\[DBP\\] \\\u003C 50 mmHg)\n      * Cardiac ejection fraction outside institutional range of normal or \\\u003C 50% (whichever is higher) as measured by echocardiogram (or multigated acquisition \\[MUGA\\] scan if an echocardiogram can't be performed or is inconclusive); left ventricular ejection fraction (LVEF) below lower limit of normal for site\n    * Patients should not have any of the following criteria:\n\n      * With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of registration\n      * Hemoglobin \\\u003C 9 g\u002FdL (\\\u003C 5.59 mmol\u002FL); note: any blood transfusion must be \\>= 14 days prior to the determination of a hemoglobin \\>= 9 g\u002FdL (\\>= 5.59 mmol\u002FL)\n      * Proteinuria 3+ on dipstick analysis or \\> 500 mg\u002F24 hours\n      * Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of capivasertib\n      * History of hypersensitivity to active or inactive excipients of capivasertib or drugs with a similar chemical structure or class to capivasertib\n      * Current disease or condition known to interfere with absorption, distribution, metabolism, or excretion of drugs\n      * Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\n      * Previous allogeneic bone marrow transplant\n      * Known immunodeficiency syndrome\n* Concomitant medications (only regarding NF2\u002FCDKN2A\u002FCDK4\u002FCDK6\u002FCCND1\u002FCCND2\u002FCCND3\u002FCCNE1\u002FAKT1\u002FPIK3CA\u002FPTEN genetic alterations):\n\n  * Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study for patients with NF2 mutation enrolled to GSK2256098, as well as for patients with AKT1\u002FPIK3CA\u002FPTEN mutations enrolled to capivasertib\n  * For NF2 patients going on to receive GSK2256098 and for patients with AKT1\u002FPIK3CA\u002FPTEN mutations enrolled to capivasertib: concomitant treatment with strong CYP3A4 inducers or CYP2D6 substrates is not allowed; patients must discontinue the drug 14 days prior to registration\n  * For NF2 patients going on to receive abemaciclib: avoid concomitant use of CYP3A inducers and strong CYP3A inhibitors; use caution with coadministered moderate or weak CYP3A inhibitors\n* Diabetic status:\n\n  * For patients with NF2 or SMO\u002FPTCH1 mutations: No uncontrolled diabetes defined as a known diabetic with HBA1C \\> 7.5 OR fasting glucose \\> 140 mg\u002FdL.\n  * For patients with AKT1\u002FPIK3CA\u002FPTEN mutations:\n\n    * Glycosylated hemoglobin (HbA1C) \\\u003C 8.0% (63.9 mmol\u002Fmol)\n    * No type 1 diabetes mellitus\n    * No requirement for insulin for routine diabetic management and control\n    * No requirement for more than two oral hypoglycemic medications for routine diabetic management and control\n    * Patients with a pre-existing diagnosis of type 2 diabetes mellitus must have fasting glucose \\\u003C 9.3 mmol\u002FL (167mg\u002FdL); fasting is defined as no caloric intake for at least 8 hours\n  * Patients without a pre-existing diagnosis of type 2 diabetes mellitus must have fasting glucose =\\\u003C 7.0 mmol\u002FL (126 mg\u002FdL); fasting is defined as no caloric intake for at least 8 hours\n* Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Creatinine OR =\\\u003C 1.5 mg\u002Fdl x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \\> 50 mL\u002Fmin\n* Urine protein:creatinine ratio (UPC) =\\\u003C 45 mg\u002Fmmol\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN); except in case of Gilbert's disease\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* Sodium, potassium, total calcium (corrected for serum albumin) \\& phosphorus within normal limits per institutional guidelines\n* QTcF \\\u003C 450 msec (QT calculated using Fridericia formula)\n* Mean resting heart rate (determined from EKG) 50-100 beats per minute (BMP) (must be obtained from 12-lead EKG defined by a triplicate EKG for patients assigned to the capivasertib arm; patients assigned to all other arms will require a single EKG\n* No uncontrolled medical comorbidities per investigator discretion (e.g. interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or pre-existing Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)\n* ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: Hemoglobin \\>= 8 g\u002FdL\n\n  \\* Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; initial treatment must not begin earlier than the day after the erythrocyte transfusion\n* ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: Prior Treatment\n\n  * Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade =\\\u003C 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to registration; a washout period of at least 28 days is required between last chemotherapy dose and registration (provided the patient did not receive radiotherapy)\n  * Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy; a washout period of at least 28 days is required between end of radiotherapy and registration\n* ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: No active bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]); screening is not required for enrollment in the absence of symptoms\n* ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: No personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest","ALL","18 Years",{"count":19,"type":20},124,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.",[26,27,28],"Intracranial Meningioma","Recurrent Meningioma","NF2 Gene Mutation","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2015-09-28",{"date":37,"type":20},"2028-01",{"name":39,"class":40},"Alliance for Clinical Trials in Oncology","OTHER",780,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100299608","phase-3-observation-or-radiation-therapy-in-treating-patients-with-newly-diagnosed-grade-ii-meningioma-that-has-been-completely-removed-by-surgery-100299608","NCT03180268","Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery","Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION:\n* The patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings at the enrolling institution. WHO grade will be assigned according to WHO 2016 criteria\n* Gross total resection (GTR) will be interpreted as modified Simpson grade 1-3 without gross residual dural-based or extradural tumor. GTR must be confirmed both by modified Simpson grade and by post-operative magnetic resonance imaging (MRI) findings. The modified Simpson grade can be inferred from the operative report (surgeon does not need to explicitly describe the Simpson grade for the purposes of eligibility)\n* Step 1 registration must occur within 180 days of the initial surgery; this will provide sufficient time for post-operative imaging confirmation of resection extent after resolution of operative changes. Moreover, it will permit additional surgery if needed to achieve a GTR. Within this 180 day interval, a second surgery is permitted in order to achieve GTR, but even with a second surgery, Step 1 registration must occur within 180 days of the initial resection\n* GTR must be confirmed on post-operative imaging following the most recent surgery. For protocol enrollment, the assessment of GTR will be made at each site. However, submission of both pre-operative and post-operative MRIs is required for patients. If a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained. All sequences obtained in the pre- and post-operative MR imaging are to be submitted to National Radiology Group (NRG) Oncology for study registration. The post-operative MRI must be completed within sufficient time to permit step 1 registration within 180 days of the initial resection. These same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, step 1 registration must still occur with 180 days of initial surgery. Computed tomography (CT) imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry\n* NOTE: Central pathology review must occur between steps 1 and 2 of registration. Once appropriate pathology specimens are received, central pathology review will occur within 10 business days, and must confirm WHO grade II meningioma before the patient can proceed to step 2 registration and randomization\n* PRIOR TO STEP 2 REGISTRATION:\n* Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration\n* Age \\>= 18\n* History\u002Fphysical examination, including neurologic examination within 60 days prior to step 2 registration\n* Post-operative Zubrod performance status 0-1 within 60 days prior to step 2 registration\n* If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception\n\nExclusion Criteria:\n\n* Optic nerve sheath meningioma, spinal or other extracranial meningioma, multiple meningiomas, hemangiopericytoma\n* Definitive evidence of metastatic meningioma (metastasis, although rare, can occur and is exclusionary)\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, cervix, melanoma in situ, or other non-invasive malignancies are permissible)\n* Previous radiotherapy to the scalp, cranium, brain, or skull base and radiation-induced meningiomas\n* Major medical illnesses or psychiatric impairments, which in the investigators opinion, will prevent administration or completion of the protocol therapy and\u002For preclude informed consent; these include, but are not restricted to:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization at the time of step 2 registration\n  * Transmural myocardial infarction within the last 6 months prior to step 2 registration\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration\n  * Type II neurofibromatosis (NF2)\n  * Ailments entailing substantial increases in sensitivity and side effect risk from radiation therapy (ataxia telangiectasia, Nijmegen breakage syndrome, and human immunodeficiency virus (HIV) with CD4 count \\\u003C 200 cells\u002Fmicroliter); HIV testing is not required for eligibility for this protocol, and known HIV positive patients are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count \\>= 200 cells\u002Fmicroliter within 30 days prior to step 2 registration\n  * Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, gadolinium allergy or renal dysfunction preventing the patient from receiving gadolinium- institutional guidelines should be used to determine if patients are at risk for renal dysfunction). Note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia",{"count":50,"type":20},163,[52],"PHASE3","This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.",[55,26],"Grade 2 Meningioma","2026-06-22",{"date":58,"type":33},"2026-06-25",{"date":60,"type":33},"2017-09-12",{"date":62,"type":20},"2027-06-15",{"name":64,"class":40},"NRG Oncology",215,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100621888","psychometric-validation-of-the-mqol-fr-and-descriptive-assessment-of-quality-of-life-in-patients-with-meningiomas-100621888","NCT07376473","Psychometric Validation of the MQOL-FR and Descriptive Assessment of Quality of Life in Patients With Meningiomas","MenQOL 2","Inclusion Criteria :\n\n* Inclusion Criteria:\n* Age ≥ 18 years\n* Diagnosis of intracranial meningioma on imaging and\u002For confirmed by surgery\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Individuals deprived of liberty by judicial\u002Fadministrative decision or under compulsory psychiatric care\n* Insufficient French language proficiency\u002Fcomprehension\n* Unable to complete the questionnaires independently\n* Unable to express non-opposition to participation","60 Years",{"count":75,"type":20},238,"OBSERVATIONAL","This non-interventional study aims to validate the French version of a meningioma-specific quality-of-life questionnaire (MQOL-FR) and to describe health-related quality of life in adults diagnosed with an intracranial meningioma.\n\nParticipants will be invited to complete online questionnaires through a secure REDCap link. After reading the study information and recording their non-opposition, participants will complete: (1) MQOL-FR (meningioma-specific), (2) EQ-5D-5L (generic health-related quality of life), and (3) FACT-Br (brain tumor-specific quality of life). The questionnaire session takes approximately 30-45 minutes and can be completed in more than one sitting using a REDCap access code. There is no additional visit and no change in usual care.\n\nThe study will recruit adults (≥18 years) with a meningioma diagnosis based on imaging and\u002For confirmed by surgery, through the GHU Paris-Sainte-Anne neurosurgery clinic and through patient\u002Fcommunity networks. The goal is to obtain 100 fully completed MQOL-FR questionnaires suitable for psychometric analyses.",[26,79,80],"Meningioma","Health-related Quality of Life",[82,83,84,85,86,87,88,89,90,91,92,93,94,95],"meningioma","intracranial meningioma","quality of life","health-related quality of life","HRQoL","patient-reported outcomes","PRO","questionnaire validation","psychometric validation","MQOL","FACT-Br","EQ-5D-5L","REDCap","neurosurgery","NOT_YET_RECRUITING","2026-01-30",{"date":99,"type":33},"2026-02-03",{"date":101,"type":20},"2026-02-02",{"date":103,"type":20},"2026-09-02",{"name":105,"class":40},"Centre Hospitalier St Anne",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":112,"enrollmentInfo":113,"targetDuration":115,"studyType":76,"phases":4,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100503195","cognition-preserving-brain-irradiation-for-treating-patients-with-intracranial-meningioma-in-the-era-of-modern-radiotherapeutic-techniques-including-proton-beam-therapy---a-prospective-study-focusing-on-radiological-outcomes-and-neurocognitive-endpoints-100503195","NCT05832099","Cognition-preserving Brain Irradiation for Treating Patients With Intracranial Meningioma in the Era of Modern Radiotherapeutic Techniques Including Proton Beam Therapy - a Prospective Study Focusing on Radiological Outcomes and Neurocognitive Endpoints","Inclusion Criteria:\n\n* Patients with clinically or pathologically-confirmed intracranial non-malignant meningiomas who are at least 18 years old, referred for arranging conformal radiotherapy\n* A Fair\u002Fgood performance status superior to Eastern Cooperative Group (ECOG) of 2 or an acceptable performance status of Karnofsky Score (KPS) at least 70\n\nExclusion Criteria:\n\n* History of prior radiotherapy delivered to brain\u002Fhead region for any reason, including stereotactic radiosurgery\n* Patients with malignant meningiomas diagnosed pathologically (WHO grade III)\n* Patients with presumed clinical target volume (CTV) encompassing bilateral peri-hippocampal regions within 5 mm away from the adjacent periphery of the hippocampus\n* Patients whose quality of volumetric MRI fails to meet the minimal requirements for physicians to delineate the hippocampal contouring (i.e., slice thickness \\> 2mm)","85 Years",{"count":114,"type":20},74,"24 Months","【Background】For cranial-irradiation-naive patients with intracranial meningiomas at risk of local recurrence, the administration of conformal cranial radiotherapy can enhance tumor control in the current era of modern radiotherapeutic techniques. Life expectancy in patients with intracranial meningiomas, particularly non-malignant meningiomas (WHO grade I and II) is essentially similar to people of general population. However, RT-related neurocognitive function (NCF) sequelae are potentially and seriously a concern which should not be ignored. In terms of the natural course of cranial irradiation-induced NCF decline, it might vary considerably according to the specific domains which are selected to be measured. Early neurocognitive decline principally involves impairments of episodic memory, which is significantly associated with functions of the hippocampus. Additionally, the extent of changes in hippocampal volume after local irradiation may be associated with the hippocampal dosimetry. This study thus aims to investigate the potential cause-effect relationship between the hippocampal dosimetry and radiological outcomes represented by the volumetric changes regarding the contralateral hippocampus; furthermore, the correlation between radiological outcomes and neurocognitive endpoints will be examined and clarified.\n\n【Methods】Patients with cranial-RT-naive intracranial meningiomas may be eligible and therefore enrolled in this prospective study addressing both radiological outcomes and neurocognitive endpoints. All eligible and recruited patients should receive baseline volumetric brain MRI examination and baseline neurobehavioral assessment. Subsequently, conformal cranial irradiation in the era of modern radiotherapeutic techniques (including hypofractionated stereotactic radiotherapy, proton beam therapy volumetric modulated arc therapy) will be utilized in order to reduce the dose irradiating the contralateral hippocampus and other relevant organs at risk. The prescribed dose schemes for treating patients with intracranial meningioma depend on the decision of the radiation oncologist in charge and follow the treatment guidelines at our cancer center. Accordingly, a battery of neurocognitive measures, which includes 9 standardized neuropsychological tests categorized into 5 NCF domains (e.g., executive functions, verbal \\& non-verbal memory, working memory, psychomotor speed, and amygdala-related emotion recognition), is used to evaluate neurocognitive performances longitudinally for our registered patients. There will be two co-primary outcome measures in the current study. The main primary outcome will be the correlation between the mean hippocampal dose and the extent of change in hippocampal volume at 6 months after the course of cranial RT. The other primary endpoint will be 6-month cognitive-deterioration-free survival.\n\n【Expected Results】This prospective observational cohort study aims to explore and investigate the cause-effect relationship between the hippocampal dosimetry (i.e., mean dose irradiating the hippocampus, particularly the one contralateral to the lateralization of intracranial meningioma) and the extent of hippocampal atrophy signifying one of the measures regarding radiological outcomes. Simultaneously, predefined standardized neurocognitive outcome measures such as hippocampus-related memory functions and amygdala-related emotion recognition will be obtained prospectively and longitudinally in order to examine whether any meaningfully significant correlation exists between the above radiological outcome measures and neurocognitive endpoints. The mutual associations among hippocampal dosimetry, radiological outcomes including the MRI-delineated hippocampal volume, and neurocognitive endpoints including hippocampus-related verbal\u002Fnon-verbal memory functions will be examined thoroughly.",[26],[26,119,120,121,122,123,124,125,126,127,128,129,130],"Radiation Therapy","Magnetic Resonance Image (MRI)","Volumetric MRI","Functional MRI (fMRI)","Radiological Outcomes","Hippocampus","Neurocognitive Functions (NCFs)","Cognition-Preserving Brain Radiotherapy","Proton Beam Radiotherapy","Hippocampal Atrophy","Amygdala","Thalamus","2023-04-14",{"date":133,"type":33},"2023-04-27",{"date":135,"type":20},"2023-08-01",{"date":137,"type":20},"2026-07-31",{"name":139,"class":40},"Chang Gung Memorial Hospital",1]